Bilateral Superficial Cervical Block for Thyroidectomy

Cervical Pain Clinical Trial

Official title:

Evaluation of the Postoperative Analgesic Efficacy of Bilateral Superficial Cervical Block for Thyroidectomy and Mini Incision Under General Balanced Anesthesia: a Randomized, Triple Masked, Placebo Controlled Trial.

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01171885
• Other study ID #: CAAE-0003.0.419.419-0
• Status: Unknown status
• Phase: Phase 4
• First received: July 28, 2010
• Last updated: July 28, 2010
• Start date: July 2009
• Est. completion date: December 2011

Study information

• Verified date: May 2009
• Source: Lifecenter Hospital
• Contact: Carlos Leonardo A Boni, MD
• Phone: 00553191851959
• Email: leonardoboni[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to compare the postoperative analgesia afforded by bilateral superficial cervical block using different concentrations of local anesthetic (ropivacaine) in patients undergoing total thyroidectomy for the mini-incision technique, performed by the same surgical team.

Description:

In this study we will evaluate the efficacy of bilateral superficial cervical block associated with balanced general anesthesia with remifentanil as opioid of choice in preventing postoperative pain in patients who underwent total thyroidectomy with mini incision without neck dissection.A hundred and twenty patients ASA I - II will be assessed and allocated randomly (through a table of random numbers) into three groups for analgesia for post-operative:

Group 1: bilateral superficial cervical block with 20 ml of 0.9% saline (placebo); Group 2:

bilateral superficial cervical block with 20 ml ropivacaine 0.25%; Group 3: bilateral superficial cervical block with 20 ml ropivacaine 0.5%.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 120
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age greater than 18 years

• Agreed to participate in the study and sign the consent form

• ASA I-II

• Scheduled to undergo total thyroidectomy without neck dissection under general balanced anesthesia.

Exclusion Criteria:

• Clinical history or laboratory tests suggestive of bleeding disorder

• Mental or cognitive deficit in existence, which makes it impossible to understand the patient visual analog scale of pain or the study protocol

• Body mass index greater than 45

• History of allergy to local anesthetics

• Intolerance or contraindication to any medication used in the study

• Skin infection at the site of the blockade

• Patients requiring neck dissection

• Pregnancy

• Preoperative use of opioid analgesics or non-opioids, corticosteroids or anti inflammatory non steroidal

• Patient's refusal to participate in the study

• Need for emergency reintervention within the first 24 hours postoperatively

Related Conditions & MeSH terms

• Cervical Pain
• Neck Pain

Intervention

Drug:
• 0.9% saline
20 ml of 0.9% saline
• Ropivacaine
20 ml of Ropivacaine 0.25%.
• Ropivacaine
20 ml of Ropivacaine 0.5%.

Locations

Country	Name	City	State
Brazil	Lifecenter Hospital	Belo Horizonte	Minas Gerais

Sponsors (2)

Lead Sponsor	Collaborator
Lifecenter Hospital	Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Andrieu G, Amrouni H, Robin E, Carnaille B, Wattier JM, Pattou F, Vallet B, Lebuffe G. Analgesic efficacy of bilateral superficial cervical plexus block administered before thyroid surgery under general anaesthesia. Br J Anaesth. 2007 Oct;99(4):561-6. Epub 2007 Aug 6. — View Citation

Eti Z, Irmak P, Gulluoglu BM, Manukyan MN, Gogus FY. Does bilateral superficial cervical plexus block decrease analgesic requirement after thyroid surgery? Anesth Analg. 2006 Apr;102(4):1174-6. — View Citation

Herbland A, Cantini O, Reynier P, Valat P, Jougon J, Arimone Y, Janvier G. The bilateral superficial cervical plexus block with 0.75% ropivacaine administered before or after surgery does not prevent postoperative pain after total thyroidectomy. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):34-9. — View Citation

Steffen T, Warschkow R, Brändle M, Tarantino I, Clerici T. Randomized controlled trial of bilateral superficial cervical plexus block versus placebo in thyroid surgery. Br J Surg. 2010 Jul;97(7):1000-6. doi: 10.1002/bjs.7077. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative pain assessment according to Visual Analogue Scale		24 Hours
Secondary	Consumption of morphine		24 Hours